|
Device | COROX OTW (-S) BP STEROID-ELUTING LEADS |
Generic Name | Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P070008 |
Supplement Number | S004 |
Date Received | 06/04/2008 |
Decision Date | 07/01/2011 |
Product Code |
NKE |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR A SECOND MANUFACTURER OF THE STEROID COLLAR, AND SECOND SOURCE OF DEXAMETHASONE ACETATE (DXA) USED FOR PRODUCTION OF THE STEROID COLLAR. |